Canada to start domestic production months after COVID-19 vaccine deadline

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The federal government has announced an agreement with U.S. vaccine maker Novavax, Inc. to manufacture its COVID-19 vaccine candidate in Canada, but production will only start months after Prime Minister Justin Trudeau’s stated deadline to procure enough vaccines for all Canadians.

Amid a series of cuts to Canada’s supply of Moderna and Pfizer-BioNTech COVID-19 vaccines, Mr. Trudeau on Tuesday announced two deals to make COVID-19 vaccines on Canadian soil. But the earliest vaccine production will start is the end of 2021.

That falls well after Mr. Trudeau’s pledge to get enough vaccines for all Canadians by the end of September and won’t change the uncertainty in the current supply chain. However, experts say the longer-term investments will help to ensure Canada is better prepared for the next pandemic and give the country more options as it moves toward an unpredictable end to the COVID-19 crisis.

“What we’re very clear on is Canada will be developing domestic manufacturing. So regardless of what could happen in the future, we will have domestic production,” Mr. Trudeau said.

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In December, The Globe and Mail reported on Canada’s faltering attempts to build domestic manufacturing capacity. Investments at the National Research Council’s Montreal campus were supposed to ensure hundreds of thousands of doses would be produced there as of November, 2020. Now the earliest Canada will produce COVID-19 vaccines is the end of 2021. Britain also had to build up capacity at the start of the pandemic but has been able to move faster. One of its facilities opening this summer will be able to produce and package a range of vaccine types.

Mr. Trudeau also announced Precision NanoSystems Incorporated (PNI) will get up to $25.1-million. The Vancouver-based biotechnology company is building a biomanufacturing centre. It will be operational in March, 2023. Canada has previously given the company $18.2-million to develop its COVID-19 vaccine candidate.

The deal closest on the horizon in Canada would have Novavax produce two million doses of COVID-19 vaccine per month once the NRC facility opens. The federal government is spending $126-million on the new building, which is still under construction and still needs Health Canada certification.

Novavax submitted its COVID-19 vaccine candidate to Health Canada for regulatory review on Friday. Ottawa has struck a deal with the pharmaceutical company to buy 52 million doses of its vaccine, and negotiated options to buy 24 million more doses.

The company said Canada’s initial order will be filled before the NRC facility is ready, but the domestic manufacturing agreement is meant to address the likelihood that Canadians will need to get repeated COVID-19 shots as immunity changes.

“The idea was to provide for what will likely be the ongoing need for a vaccine for the foreseeable future,” said John Trizzino, chief commercial officer for the company, which is headquartered in Gaithersburg, Md.

The government has not released any of its vaccine contracts, nor has it released either an individual or total cost for the 234 million COVID-19 vaccines it has purchased through seven different contracts.

The Novavax deal was struck through a memorandum of understanding; the final agreement is not yet completed, according to John Power, a spokesperson for Industry Minister François-Philippe Champagne. Mr. Power was unable to provide a cost for the agreement or say when the interim deal was signed.

When production would actually start was a moving target on Tuesday. Mr. Trudeau said the NRC would have “vaccine production capacity as of this coming summer.” But within an hour of Mr. Trudeau’s press conference, Mr. Champagne said production would start “by the end of the year.”

HOW THE NOVAVAX VACCINE WORKS

Unlike other vaccines that Health Canada has authorized or is considering, the Novavax vaccine does not involve the delivery of genetic information into human cells. Instead, it consists of tiny particles adorned with coronavirus proteins which train the immune system to fight off a genuine infection.

VACCINE NANOPARTICLE

Vaccine nanoparticles are covered in synthesized coronavirus spike proteins.

ANTIGEN-

PRESENTING

CELL

Coronavirus

protein

Nanoparticles are broken down by antigen-presenting cells which display protein parts to the immune system.

Antibody

Immune system produces antibodies that can bind to the spike protein of a real virus.

The immune system is now primed to recognize the coronavirus and generate antibodies that prevent the virus from attaching to host cells via the ACE2 receptor.

COVID-19

virus particle

ACE2

receptor

MURAT YÜKSELIR AND IVAN SEMENIUK /

THE GLOBE AND MAIL

HOW THE NOVAVAX VACCINE WORKS

Unlike other vaccines that Health Canada has authorized or is considering, the Novavax vaccine does not involve the delivery of genetic information into human cells. Instead, it consists of tiny particles adorned with coronavirus proteins which train the immune system to fight off a genuine infection.

VACCINE NANOPARTICLE

Vaccine nanoparticles are covered in synthesized coronavirus spike proteins.

ANTIGEN-

PRESENTING

CELL

Coronavirus

protein

Nanoparticles are broken down by antigen-presenting cells which display protein parts to the immune system.

Antibody

Immune system produces antibodies that can bind to the spike protein of a real virus.

The immune system is now primed to recognize the coronavirus and generate antibodies that prevent the virus from attaching to host cells via the ACE2 receptor.

COVID-19

virus particle

ACE2

receptor

MURAT YÜKSELIR AND IVAN SEMENIUK /

THE GLOBE AND MAIL

HOW THE NOVAVAX VACCINE WORKS

Unlike other vaccines that Health Canada has authorized or is considering, the Novavax vaccine does not involve the delivery of genetic information into human cells. Instead, it consists of tiny particles adorned with coronavirus proteins which train the immune system to fight off a genuine infection.

VACCINE NANOPARTICLE

Vaccine nanoparticles are covered in synthesized coronavirus spike proteins.

ANTIGEN-

PRESENTING

CELL

Coronavirus

protein

Nanoparticles are broken down by antigen-presenting cells which display protein parts to the immune system.

Antibody

Immune system produces antibodies that can bind to the spike protein of a real virus.

The immune system is now primed to recognize the coronavirus and generate antibodies that prevent the virus from attaching to host cells via the ACE2 receptor.

COVID-19

virus particle

ACE2

receptor

MURAT YÜKSELIR AND IVAN SEMENIUK / THE GLOBE AND MAIL

In a statement, the NRC further hedged on the timeline. It underscored there are “several steps” needed before vaccine production can start including: creating the vaccine-specific production process, verifying its accuracy through process qualification, and then Health Canada regulatory checks and approval.

“Initial engineering runs at the Biologics Manufacturing Centre are targeted for December 2021, with full production runs to follow shortly after,” the statement from the NRC said.

Last week Novavax released data from a 15,000-participant clinical trial in Britain showing that the vaccine exhibited 96-per-cent efficacy against the original form of the virus and 86 per cent against the now-surging British variant.

The Novavax product may become the first protein-based COVID-19 vaccine authorized in Canada. The vaccine includes an adjuvant – a compound that jump-starts the immune system and helps generate a better immune response to the proteins. Currently, there are no plans to make the adjuvant in Canada, Mr. Trizzino said.

Prior to the Canadian announcement, Novavax had already announced it would be manufacturing its vaccine at two sites in the United States and six more in other countries. Mr. Trizzino expects that the Canadian site will require 200 to 300 staff to operate.

Amine Kamen, the Canada Research Chair in Bioprocessing of Viral Vaccines, said the investment in domestic vaccine production is “excellent news” but the availability of highly qualified professionals will be a “limiting factor.”

In the short term, provinces are contending with fluctuating delivery schedules. Deliveries from Pfizer-BioNTech are supposed to pick up at the end of February. Shipments from Moderna were cut this week and information about a subsequent delivery was removed from a federal website. The Public Health Agency of Canada said the shipment is still coming but the number of doses is being finalized. The shipment was previously expected to hold 249,600 shots.

A “rapid supply” of vaccines that can be administered “as soon as possible” is crucial, especially given the spread of new, more dangerous, variants of COVID-19 in Canada, said David Naylor, co-chair of the federal COVID-19 Immunity Task Force. However, he said if Canada can start producing vaccines in the fall it would still be helpful.

“The emergence of variants is a reminder that a soft landing isn’t assured,” Dr. Naylor said. “It may be necessary to reimmunize large numbers of people, modifying the vaccines, as happens annually to cover different strains of influenza.”

Conservative Leader Erin O’Toole said Tuesday his party welcomes the news that Canada will have domestic capacity, but he questioned why the Liberals took so long to act. “How does today’s announcement help us now?” he asked.

If the lack of domestic capacity had been addressed earlier, NDP Leader Jagmeet Singh said, “it would have addressed a lot of the insecurity people are feeling about not getting the vaccine.”

With reports from Laura Stone and Paul Waldie

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